The MedTech Strategist, Vol. 4, No. 10, July 5, 2017 MTS 7-5-17 joomag

JULY 5, 2017 Vol. 4, No. 10 Published by Innovation In Medtech, llc DIGITAL HEALTH MindUP—An Israeli Incubator in Digital Health NEUROLOGY Device Market for David Cassak, 6 Ischemic Stroke Gains Momentum Mary Stuart, 16 12 th Annual Molecular Diagnostics Update DIAGNOSTICS MARKET OUTLOOK We estimate the molecular diagnostics industry grew 9.4% in constant currency to $7.6 billion in 2016 (up 9.6% reported), a moderate improvement to 2015’s 9.2% constant currency growth (7.5% reported), driven by infectious, sexually transmitted and hospital-acquired disease testing with the strongest outperformance in multiplex panels. The industry also benefited from accelerating uptake of large genetic panel and non-invasive prenatal testing. Solid performance during the year was partially offset by flat growth in blood screening and continued HPV pressure. We forecast similar growth during 2017 with a moderate growth acceleration in 2018 and 2019, following advances in microbiology, new launches within viral load and growing traction of value- add genetic tests. The new administration has made it clear new regulations will come at a premium and thus the diminished overhang from FDA regulation of laboratory-developed tests is clear (at least until the next administration). Additionally, the final PAMA rules came and went with many specialty labs likely to benefit from the move to market-based pricing as Medicare was often at or below private payer rates. The more commoditized tests (such as MRSA & CT/NG) will likely see some reimbursement pressure from PAMA, but we point out that an ~$80 test moving to ~$72 is unlikely to negatively affect the manufacturers (when considering the tests themselves are being sold at ~$10-$15/test). The big remaining factor is whether PAMA is delayed to 2019 as industry stakeholders have speculated. Having attended Washington D.C. policy meetings, we remain in the January 2018 implementation date camp. No More Doldrums: A Positive Take on Pulse Therapeutics: Making tPA More Effective, 23 In the Stroke Pipeline, 24 Molecular Diagnostics Wendy Diller, 28 MARKET TRACK Exhibit 1 $7.6B Molecular Diagnostics Market Improving Growth Prospects for the $7.6B Molecular Dx Market See page 29 START-UPS TO WATCH IVENIX: A Modern Infusion Solution for Age-Old Challenges Colin Miller, 34 CORVIA MEDICAL: Finally, an Intervention for the Other Half of Heart Failure Mary Stuart, 36 Source: Piper Jaffray Research WWW. M ED T ECH S TRATEGIST .COM